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Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Last updated on March 31, 2020

FOR MORE INFORMATION
Study Location
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ineligibility for participation in any ongoing clinical study of the investigational
product

- Age ≥18 years

- Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK
rearrangement or a ROS1 rearrangement

- For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If
prior ALK-TKI was crizotinib, additional prior treatment required with at least one
second generation ALK-TKI registered and commercially available. For patients with
resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance
mutation), prior treatment with an ALK/ROS1 inhibitor is not required.

- For ROS1 positive patients: failure to prior treatment with at least crizotinib

- Adequate bone marrow, liver, renal, pancreatic functions

- Negative pregnancy test at screening

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or
participation in other studies with investigational drugs within the timeframe
indicated in the protocol

- History of interstitial fibrosis or interstitial lung disease

- Concomitant use of prohibited medication

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke,
myocardial infarction, unstable angina, congestive heart failure, second degree or
third degree atrioventricular block (unless paced) or any AV block with PR >220 msec

- Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with
QTc >470 msec, or congenital long QT syndrome

- History of or predisposing characteristics for acute pancreatitis

NCT03178071
Pfizer
No longer available
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

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Descriptive Information
Brief Title Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Official Title AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
Brief Summary This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
Detailed Description Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Intervention Drug: Lorlatinib
oral tablets, administered daily, continuously
Other Name: PF-06463922
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Eligibility Criteria

Inclusion Criteria:

  • Ineligibility for participation in any ongoing clinical study of the investigational product
  • Age ?18 years
  • Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
  • For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.
  • For ROS1 positive patients: failure to prior treatment with at least crizotinib
  • Adequate bone marrow, liver, renal, pancreatic functions
  • Negative pregnancy test at screening

Exclusion Criteria:

  • Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
  • History of interstitial fibrosis or interstitial lung disease
  • Concomitant use of prohibited medication
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR >220 msec
  • Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc >470 msec, or congenital long QT syndrome
  • History of or predisposing characteristics for acute pancreatitis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03178071
Other Study ID Numbers B7461020
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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